Kornimate/medical-research-clean huggingface dataset:
factors influencing volumetric mr-hifu ablation of uterine fibroids

Conditions: Uterine Fibroid

Summary: magnetic resonance (mr)-guided high-intensity focused ultrasound (hifu) ablation is increasingly being used worldwide to treat symptomatic uterine fibroids because of its excellent therapeutic efficacy in controlling symptoms and its excellent safety record. despite the benefits, it should be recognized that mr hifu ablation does not always yield good therapeutic outcomes. high signal intensity on t2-weighted mr images and a high volume transfer constant (or ktrans) on dynamic contrast material-enhanced mr images are the most well-known risk factors for poor ablation outcomes as measured with the non-perfused volume (npv) ratio (ie, npv divided by fibroid volume). the aim of this study is to assess the influence of fibroid perfusion (evaluated by mri and contrast enhanced ultrasound), apparent diffusion coefficient (evaluated by mr-diffusion imaging) and fibroid stiffness (evaluated by arfi) on ablation efficiency during uterine fibroid treatment by mr-hifu.

preprocedural predictors of treatment efficacy will be useful for excluding in advance patients who would not benefit from this treatment, thereby contributing to improved overall clinical outcomes. during ablathermy treatment lost of energy depend of tissue perfusion and thermic diffusion while energy laying depend of tissue absorption coefficient. study these parameters before treatment could bring important information to the treatment difficulty and its efficacy. the investigators will study and compare fibroid perfusion with dynamic contrast-enhanced magnetic resonance imaging and contrast-enhanced ultrasound (ceus). ceus will be performed with contrast agent (sonovue). thermic diffusion could be linked with fibroid stiffness. fibroid stiffness will be quantified with velocity of shear wave measured by acoustic radiation force impulse (arfi). tissue absorption coefficient is correlated with the architecture and the cellularity of the tissue so the investigators think that apparent diffusion coefficient (computed with diffusion weighted imaging) could be correlated with ablathermy efficiency and other intra procedural thermal parameters.

Eligibility criteria:
inclusion criteria: * woman * aged more than 18 years * not postmenopausal * having one or two symptomatic fibroid with size \< 15cm. * symptoms severity score (sss) score on uterine fibroid symptoms related quality of life (ufs-qol) ≥ 10 * signed informed consent prior to any study related procedure * with a medical insurance exclusion criteria: * contraindicated to mr examination, sonovue and gadolinium contrast injection (pregnancy etc..). * presence or suspicious of pelvic malignant tumor

Keywords: mr-hifu hifu fibroid treatment mr perfusion ceus perfusion diffusion weighted imaging arfi fibroid stiffness
a study to evaluate response of over active bladder symptom score to solifenacin treatment

Conditions: Over Active Bladder

Summary: this study is to evaluate change of over active bladder symptom scores (oabss) between, before and after solifenacin treatment to oab subjects.


Eligibility criteria:
inclusion criteria: * symptoms of oab for 3 months or longer * at least 1 urgency episode in last 3 days * symptoms of oab as verified by the screening 3-day bladder diary, defined by: * a. number of micturition ≥8 times/day * b. number of urgency episodes in 3 days ≥3 exclusion criteria: * significant stress incontinence or mixed stress/urge incontinence * subject with indwelling catheters or practicing intermittent self-catheterization * symptomatic urinary tract infection, chronic inflammation * diabetic neuropathy * subjects who are prohibited from taking solifenacin as contraindications * drug or non-drug treatment for oab was started, quitted or changed in 4 weeks * participation in any clinical trial in 30 days except for part-1 of resort * diabetic neuropathy

Keywords: oabss ipss ppbc solifenacin
efficacy and safety of saccharomyces boulardii in the treatment of small intestinal bacterial overgrowth

Conditions: Irritable Bowel Syndrome

Summary: non-constipated irritable bowel syndrome is a common disorder that may be related to small intestinal bacterial overgrowth. saccharomyces boulardii cncm i-745 is a probiotic yeast that has proven efficacy for the treatment of acute gastroenteritis and antibiotic-associated diarrhea. however, its efficacy for the treatment of diarrhea-predominant irritable bowel syndrome with small intestinal bacterial overgrowth has not been assessed. hence, an exploratory randomized, open label trial comparing the efficacy and safety of saccharomyes boulardii cncm i-745 plus diet administration versus diet administration only for 15 days among adult patients with the aforementioned condition was conducted.


Eligibility criteria:
inclusion criteria: * adult patients * diagnosis of irritable bowel syndrome according to rome iii criteria * diagnosis of concomitant small intestinal bacterial overgorwth (sibo) by breath test exclusion criteria: * pregnancy * diagnosis of celiac disease * diagnosis of inflammatory bowel disease or other immune-mediated gastrointestinal conditions * immunosuppression * diagnosis of active cancer
act for hiv-positive men

Conditions: Stress; Anxiety; Mental Disorder; Distress-based Psychopathology

Summary: the purpose of the current study is to examine the feasibility and effectiveness of acceptance and commitment therapy, a specific form of cognitive-behavioral therapy, for treating general mental health concerns among hiv-positive men.

the purpose of the current study is to examine the feasibility and effectiveness of acceptance and commitment therapy, a specific form of cognitive-behavioral therapy, for treating general mental health concerns among hiv-positive men.

Eligibility criteria:
inclusion criteria: * identify as a man * be at least 18 years old * has been diagnosed with hiv by a healthcare professional exclusion criteria: * has engaged in self-harm within the last three months * has attempted suicide within the last year * has had an active plan to attempt suicide within the last 30 days * is currently diagnosed with any eating disorder * has experienced hallucinations or delusions within the last 30 days * has used narcotics within the last 7 days (heroin, meth, crack cocaine, opioids)
exercise prehab in older adults with hematologic malignancies

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Summary: this pilot trial studies a structured exercise program intervention in improving physical activity in older patients with hematologic malignancies undergoing cancer therapy. patients with hematologic malignancies are at an increased risk of functional dependence and injury. structured exercise programs, such as the otago exercise programme (oep), may improve balance, strength, and prevent fall-related injury in older patients with hematologic malignancies undergoing cancer therapy.

primary objectives: i. to assess the feasibility of implementing a structured exercise program by evaluating recruitment and retention, exercise program adherence, sustainability, adverse events, and implementation challenge. secondary objectives: i. to calculate preliminary effect sizes of the impact of an exercise program in patients with hematologic malignancy undergoing therapy, as measured by: * cancer and aging research group (carg) geriatric assessment tool parameters. * change in short physical performance battery (sppb). * number and severity of falls. * impact of motivation and self-efficacy on adherence. * hospital readmission rates (if applicable). * length of inpatient stays (if applicable). * patient reported outcome measurement information system (promis) for health related quality of life (hrql). * correlative analysis of peripheral blood biomarkers of aging and inflammation (cyclin-dependent kinase inhibitor 2a \[p16\], inflammatory biomarkers, immunosenescence, micro \[mi\] ribonucleic acid \[rna\]). outline: patients attend 8 physical therapy visits twice monthly for 4 months or until transplant. patients also undergo an individualized exercise program at home for 6 months. the program comprises 3 main components: walking over 30 minutes twice a week, strengthening and balance retraining exercise over 30 minutes three times a week. after completion of study, patients are followed up at 6 months.

Eligibility criteria:
inclusion criteria: * patients with hematologic malignancy receiving care (chemotherapy, immunotherapy, targeted agents, bone marrow transplant, or other) for their hematologic malignancy at the ohio state university * impairments in physical function, as defined by a score \< 9 on the sppb pre-screen * medical clearance from an oncologist or primary care physician stating the participant is able to participate in an unsupervised, moderate-intensity physical activity program * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * prisoners * any medical condition including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study procedures

Keywords: hematologic malignancy exercise decreased physical activity
a phase 3 study of ntla-2001 in attrv-pn

Conditions: Neuromuscular Disease; Neuromuscular Diseases (NMD); Neurodegenerative Disease; Neurodegenerative Disease, Hereditary; Neurodegenerative Diseases; Neuromuscular Diseases; Nerve Disorders; Nervous System Disease; Nervous System Diseases; Genetic Disease, Inborn; Amyloidosis, Familial; Amyloidosis, Hereditary; Amyloidosis; Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Peripheral Nervous System Disease; Peripheral Nervous System Diseases; Metabolism, Inborn Errors; Metabolic Diseases

Summary: this study will be conducted to evaluate the efficacy and safety of a single dose of nexiguran ziclumeran (ntla-2001) compared to placebo in participants with attrv-pn.

this is a multinational, multicenter, double-blind, placebo-controlled study in approximately 50 participants, who will be randomized 1:1 to receive a single infusion of either nexiguran ziclumeran or placebo. to ensure all participants will have the potential to receive nexiguran ziclumeran, participants will have the option to cross over to the opposite study arm at month 12 or month 18, depending on study criteria.

Eligibility criteria:
inclusion criteria: * diagnosis of attrv-pn * karnofsky performance status (kps) ≥ 60 exclusion criteria: * other causes of amyloidosis (amyloidosis caused by non-ttr protein) * other known causes of sensorimotor or autonomic neuropathy * diabetes mellitus * new york heart association class iii or iv heart failure * liver failure * hepatitis b, hepatitis c or human immunodeficiency virus (hiv) infection * prior receipt of a ttr silencer (small interfering rna (sirna) or antisense oligonucleotides (asos)) * estimated glomerular filtration rate \< 30 ml/min/1.73 m2 * unable or unwilling to take vitamin a supplementation for the duration of the study

Keywords: ttr amyloidosis polyneuropathy ntla-2001 attr attr-pn attrv-pn transthyretin ttr-mediated amyloidosis amyloidosis, hereditary amyloidosis, hereditary, transthyretin-related amyloidosis transthretin amyloid polyneuropathy ttr pn ttr polyneuropathy nexiguran ziclumeran nex-z
safety and effect of biphasic insulin aspart 50 in patients with type 2 diabetes mellitus.

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks. * hba1c: less than 11.0% * bmi: less than 30.0 kg/m2 exclusion criteria: * total daily insulin dose: 100 iu/u and more * treatment with oral hypoglycaemic agents within the last 4 weeks. * treatment with insulin sensitizer within the last 12 weeks * a lifestyle that is considered unsuitable for this trial (frequent or routine night shift workers etc.)
medical & economical evaluation of fenestrated & branched stent-grafts to treat complex aortic aneurysms

Conditions: Aortic Aneurysms

Summary: the aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of pararenal, supra-renal and type 4 thoraco-abdominal aortic aneurysms. the primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (250 patients (amendment) treated in 8 university hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the moh).

the aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of pararenal, supra-renal and type 4 thoraco-abdominal aortic aneurysms. the primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (250 patients (amendment) treated in 8 university hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the moh). in-hospital morbidity are similarly expected to be lower in the endovascular group. we also wish to demonstrate that endovascular repair does not represent a significant over-cost, as compared to open repair. the cost of the implantable medical device (imd), of follow-up screening, and of eventual repeated interventions should be compensated by a reduced stay in intensive care unit icu, and by a reduced in-hospital length of stay.

Eligibility criteria:
inclusion criteria: the following anatomical inclusion criteria must be met: * absence of significant angulations (\< 60°) of aorta or of iliac arteries * absence of tight stenosis (\>70%) of more than one target artery (renal or visceral artery to be perfused from the side holes of the stent-graft) * diameter of target arteries over 5 mm * iliac and femoral arteries allowing insertion of the delivery system (\> 7 mm) or suitable for insertion of an access conduit exclusion criteria: * limited expected life expectancy * emergency cases * refuse to participate to the study

Keywords: aorta aneurysm endovascular stent-graft
tumor vaccines for solid tumors

Conditions: Glioma; Solid Tumor

Summary: glioma is the most common primary malignant intracranial tumor, characterized by limited clinical treatment options and extremely poor prognosis. there is an urgent need for the development of new technologies and clinical practice. with the advancement of immunotherapy, tumor therapeutic vaccines have emerged as a hot topic in the field of solid tumor immunotherapy. several clinical trials have confirmed that tumor vaccines can improve the prognosis of glioma patients. vaccines are the first systemic treatment technology in nearly 30 years that can simultaneously extend the overall survival of patients with newly diagnosed glioblastoma and recurrent glioblastoma in phase iii clinical trials. this novel approach holds significant clinical value and brings hope to large number of patients. our team has previously developed a dendritic cell (dc) vaccine for glioma, and the phase ii clinical trial has demonstrated that it can extend the prognosis of glioma patients. however, several patients benefit less from vaccine therapy. therefore, the identification of molecular mechanisms that render patients unresponsive to vaccine treatment is critical to improving vaccine efficacy. this project aims to collect various types of clinical samples from patients, including glioma patients receiving tumor vaccine treatment, glioma patients receiving conventional clinical treatment without tumor vaccine, and non-tumor patients (hemorrhagic stroke, ischemic stroke, and traumatic brain injury). high-throughput sequencing techniques will be used to establish an immune microenvironment database, followed by bioinformatics analysis and molecular biology experiments to uncover the molecular mechanisms influencing vaccine efficacy. artificial intelligence and deep learning technologies will be employed to extract molecular mechanisms related information from radiology images and pathology images. ultimately, the project seeks to establish an integrated diagnostic and treatment model that combines imaging, pathology, and omics data to advance the clinical application of vaccines.


Eligibility criteria:
inclusion criteria: the patients with glioma patients/non-tumor patients (hemorrhagic stroke, ischemic stroke, and traumatic brain injury) in the department of neurosurgery of huashan hospital affiliated to fudan university who meet the following three conditions can be enrolled: 1. they were no age limit, male and female; 2. the pathological results of frozen section during operation were gliomas or non-tumor; 3. tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis; 4. sign informed consent. exclusion criteria: patients who meet any of the following criteria will not be included in this study: 1. participants in other clinical trials; 2. pregnant women.

Keywords: glioma dc vaccine database biomarker artificial intelligence
self-determination theory and motivational interviewing

Conditions: Schizophrenia; Diabetes

Summary: self-determination theory and motivational interviewing would be integrated to enhance the efficacy of diabetic self-management for patients with schizophrenia and type 2 diabetes.

participants would be randomly allocated into either the intervention group or the usual care group from baseline to 3 months follow-up. the intervention is based on integrated self-determination theory and motivational interviewing.

Eligibility criteria:
inclusion criteria: * patients with schizophrenia and type 2 diabetes * between 20 years old to 80 years old * can communicate in chinese langue exclusion criteria: * can not communicate well * have neurocognitive disorders
retrospective study to determine the incidence of bone fractures in hiv-infected patients in spain

Conditions: HIV

Summary: study to determine the incidence of bone fractures in hiv infected patients in spain

study to know the incidence of bone fractures in hiv patients, determine associate factors to bone fractures, the type of patients with fractures.

Eligibility criteria:
inclusion criteria: * hiv infection * signed icf * patient that fulfill these: * osteroporosis associated fracture * enough information close to the moment of the fracture exclusion criteria: * patients with cognitive impairment

Keywords: hiv
trial to assess response to oral vitamin d3 supplementation in obese individuals

Conditions: Obesity

Summary: this study is an extension of an earlier study of vitamin d supplementation conducted on normal weight individuals by dr. john aloia of the bone mineral research division at winthrop university hospital. the investigators plan to compare the response to vitamin d supplementation in obese individuals with the response already measured in normal weight individuals. the same dosing schedule of vitamin supplementation will be used as in the past. the doses used in the past have demonstrated safety in a number of trials, here at winthrop as well as outside of winthrop hospital. sixty study volunteers are planned for enrollment in the study. the study participants will mainly be recruited from a group of patients who have in the past been enrolled in the weight loss program at winthrop hospital. each participant will be on vitamin d supplementation for a total of 8 weeks. vitamin d blood levels will be measured before and at the end of the supplementation period. they will then be compared to see the change over time as a result of supplementation.


Eligibility criteria:
inclusion criteria: * obese adults aged 18-65 years and bmi\>35 exclusion criteria: * chronic medical illness (diabetes, malignancy, uncontrolled hypertension, kidney disease) * subjects who have undergone bariatric surgery or currently enrolled in a medically supervised weight loss program * bmi \< 35 * pregnancy * use of medication that influences vitamin d metabolism * history of of hypercalcemia, hypercalciuria, nephrolithiasis

Keywords: vitamin d3 obesity cholecalciferol
study of ds-1123a in advanced solid tumours

Conditions: Advanced Solid Malignant Tumors

Summary: this is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of ds-1123a in japanese subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available. * eastern cooperative oncology group performance status (ps) of 0 or 1. exclusion criteria: * have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment: • cardiac failure (nyha ≥ classiii), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia), * severe or uncontrolled concomitant disease. * clinically active brain metastases defined as symptomatic or requiring treatment.

Keywords: advanced solid malignant tumors phase 1 oncology refractory no standard treatment